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NCT07858110
Effects of Wheat Flour Milling Method on Glycemic Response and Gastrointestinal Symptoms
Conditions: Gastrointestinal Irritation, Nutrition, Healthy
Sex: All
Ages: 20 Years – 40 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 26
Sponsor: University of Bergen
Location: Research Unit for Health Surveys, University of Bergen Bergen Vestland
Summary
The goal of this clinical trial is to learn if the way wheat flour is ground - by stone milling (an older method) or roller milling (used for most flour today) - changes blood sugar levels after eating bread, in healthy adults aged 20 to 40 who eat bread regularly. The main questions it aims to answer are:
Does bread made from stone-milled flour cause a smaller rise in blood sugar after breakfast than bread made from roller-milled flour? Does the milling method change stomach symptoms such as bloating?
Researchers will compare bread made from stone-milled wheat flour to bread made from roller-milled wheat flour, made from the same wheat and prepared the same way, to see if milling method changes blood sugar and stomach symptoms.
Participants will:
Eat the study bread at breakfast and lunch for 3 days, then switch to the other bread for 3 days, in a random order Eat a standard bread for a few days before each 3-day period Wear a small sensor that tracks blood sugar day and night for 14 days Keep a daily food diary, including photos of meals Answer online questionnaires about stomach symptoms
Eligibility Criteria
Inclusion Criteria:
* BMI 18.5-25 kg/m2
* Healthy, defined by reference to the exclusion criteria below
* Habitual consumption of bread on most days, at more than one meal per day
* Willing and able to consume the study breads, to follow the standardized meal pattern for 14 days, and to wear a CGM sensor continuously for 14 days
Exclusion Criteria:
* Smoking/tobacco use
* Any disease or condition or use of drugs or other compounds or treatments that could have a clinically significant impact on energy metabolism and/or gastrointestinal health (Roma IV to rule out IBS)
* Diagnosed diabetes mellitus of any type (no screening measure of glycemic status will be obtained because sample collection is minimized within the project resources)
* Diagnosed celiac disease, or self-reported gluten or wheat sensitivity leading to habitual avoidance of wheat products
* Pregnancy or lactation
* Systemic antibiotic use within 4 weeks before the calibration visit
* Night-shift or rotating-shift work during the study period
* Skin condition at the sensor site precluding CGM wear
* No allergies to wheat/grains
Source: ClinicalTrials.gov (NCT07858110). StuddyBuddy aggregates publicly available trial information.